Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders(TMD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Temporomandibular Disorders
- Sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual analogue scale(VAS)
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes.
Detailed Description
This is a single-blinded, randomized controlled clinical trial. A total of 60 participants will be randomly assigned to two different groups. The treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the Park sham needle. All participants will be given for 4 weeks of treatment and 4 weeks of follow-up.The primary end-point is the reducing in intensity of pain due to TMD, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. Secondary end points include Graded Chronic Pain Scale Version 2.0(GCPS 2.0),Jaw Functional Limitations Scale - 20-item (JFLS-20),Depression, Anxiety and Stress Scales (DASS-21),Pittsburgh sleep quality index (PSQI),Pressure Pain Threshold (PPT),Surface electromyogram(sEMG).
Investigators
Li bin
Acupuncture director
Beijing Hospital of Traditional Chinese Medicine
Eligibility Criteria
Inclusion Criteria
- •Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- •Pain in the jaw, temple, in the ear, in front of ear or headache in the temple at any sides, and pain or headache modified (remission or aggravation) with movement at least 3 months.
- •Cooperated in completing the clinical trial successfully without language and mental disorders.
Exclusion Criteria
- •Conditions that result in regional pain in temporomandibular joint.
- •Autoimmune diseases that result in regional pain in the temporomandibular joint.
- •Mental illness or substance abuse.
- •Pregnant women.
Outcomes
Primary Outcomes
Visual analogue scale(VAS)
Time Frame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
VAS is an international scale which reflects pain intensity and it has a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (extremely painful). Pain intensity or pain relief in the tempormandibular joints will be measured by VAS. And then the investigators will compare the change of different time frames.The total score of this index is 10, and the better effect with the lower score.
Secondary Outcomes
- Surface electromyogram(sEMG)(Baseline and Week- 4(treatment period))
- Jaw Functional Limitations Scale - 20-item (JFLS-20)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))
- Depression, Anxiety and Stress Scales (DASS-21)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))
- Graded Chronic Pain Scale Version 2.0(GCPS 2.0)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))
- Pressure Pain Threshold (PPT)(Baseline and Week- 4(treatment period))
- Pittsburgh sleep quality index (PSQI)(Baseline,Week- 4(treatment period) and Week-8(follow-up period))